Relaxation of the pelvic tissue may result in prolapse of either the uterus, bladder, rectum, or intestines; it may result in stress incontinence; or it may result in a combination of the above. Surgery will effectively control the condition; but if the patient is very old, or for other reasons is a poor operative risk, a vaginal pessary may be considered. However, in this group of women, the introitus, the inlet to the vagina, may be narrow making it painful to insert the pessary. A pessary used as a prolapse device must be as large as possible to serve as a mechanical barrier, preventing the organs from being extruded through the introitus.
Various prolapse devices have been in use for several decades. They are usually made of a solid material and, to ensure that they function adequately, they have to be as large as possible. That makes it difficult and painful to insert the device and then remove it for cleaning. These devices will, if they are made inflatable, be possible to deflate to a small size for easy insertion and then inflate so that they return to normal shape and rigidity once they are in the right location. For this reason an inflatable prolapse device, the "Inflatoball", has been on sale from Milex Products, Inc., 5915 Northwest Highway, Chicago, Ill. 60631. The mechanism for deflation and inflation of the "Inflatoball" includes a tube attached to a spherical body, which tube extends to just outside the vagina when the spherical body has been properly inserted. The tube ends with a valve which can be readily opened for deflation. It can also be connected with a pump when inflation is desired. In order to minimize the discomfort caused by the tube protruding from the vagina, the tube connected to the spherical body is very short, which for many patients makes it difficult to connect the pump.
A vaginal pessary used for control of urinary incontinence also needs to be large to perform well. As a consequence, insertion and removal of the incontinence device can also be painful. An inflatable pessary for controlling incontinence, particularly stress incontinence, is disclosed in U.S. Pat. No. 5,007,894 issued on Apr. 16, 1991. The device consists of an inflatable oval-shaped body with two projections, the oval-shaped body being provided with a central aperture to allow drainage to migrate from the uterus and out of the vagina. The two projections offer support on each side of the urethra and prevent the device from exerting a direct pressure on the urethra. This pessary, with the exception of the two projections used for control of urinary incontinence, is somewhat similar to prior art devices, in the form of donuts, used for control of vaginal prolapse.
Other prior art prolapse devices which have been used to control incontinence, and which have inflatable portions, are shown in U.S. Pat. Nos. 3,646,929, 2,638,093, and 4,920,986, British patent 1,115,727 and European Patent Application 0 274 762. All of these devices have a tube which extends out of the vagina, which tubes will cause discomfort to the wearer.
As mentioned above, an inflatable pessary is for sale but has not been widely accepted. Clearly, the urinary incontinence ring, as well as the pessary used to control a prolapse, need to have a system for inflation and deflation that will not cause the patient discomfort; in fact, it should not be noticeable to the patient once the device has been inserted into the vagina. No tubing should protrude from the vagina. The device described with this application fulfills these needs.